FDA Device recall Z-1605-2016
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 202…
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 202… by Medtronic Cardiac Rhythm And Heart Failure, citing A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up con….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1605-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-31 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | n/a |
Product
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.
Reason
A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou
Identifiers
| code_info | Model Serial Number 2020B LPH003245P 2020B LPH004235P 2020B LPH004270P 2020B LPH004448P 2020B LPH004578P 2020B LP…Model Serial Number 2020B LPH003245P 2020B LPH004235P 2020B LPH004270P 2020B LPH004448P 2020B LPH004578P 2020B LPH006282P 2020B LPH006598P 2020B LPH006892P 2490C IJX010143A 2490C IJX010218A 2490C IJX010291A 2490C IJX010304A 2490C IJX010320A 2490C IJX010414A 2490C IJX010416A 2490C IJX010441A 2490C IJX010474A 2490C IJX010489A 2490C IJX010501A 2490C IJX010521A 2490C IJX014234A 2490C IJX014380A 2490C IJX014382A 2490C IJX014387A 2490C IJX014436A 2490C IJX014473A 2490C IJX014502A 2490C IJX014591A 2490C IJX019468A 2490C IJX019469A 2490C IJX019550A 2490C IJX019568A 2490C IJX019647A 2490C IJX019681A 2490C IJX019716A 2490C IJX019729A 2490C IJX019731A 2490C IJX019752A 2490C IJX019753A 2490C IJX019756A 2490C IJX019782A 2490C IJX019824A 2490C IJX019845A 2490C IJX019905A 2490C IJX019933A 2490C IJX019944A 2490C IJX019947A 2490C IJX020167A 2490C IJX020175A 2490C IJX020197A 2490C IJX020240A 2490C IJX020247A 2490C IJX020371A 2490C IJX020403A 2490C I |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1605-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.